FDA Inspection
Volk Optical IncVolk Optical Inc – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns Volk Optical Inc, with an inspection on September 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7fcf2e1d-4184-485a-907b-3b487ffdd985
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027501
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Documentation
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Other FDA inspections of Volk Optical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 24, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Volk Optical Inc
- FDA Inspection 903132 - 2014-11-06
- FDA Inspection 809759 - 2012-10-24
- FDA Inspection 589876 - 2009-06-26
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